Trial Outcomes & Findings for Behavioral Economics and Adherence in Teens (BEAT!) (NCT NCT03958331)
NCT ID: NCT03958331
Last Updated: 2022-09-23
Results Overview
A total mean adherence rates will be calculated based on daily adherence rates captured through the SimpleMed Pillboxes or AdhereTech bottles. Scores range from 0-100%, with higher scores representing better adherence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
Month 7
Results posted on
2022-09-23
Participant Flow
We had a run-in period, in which 64 participants were not randomized to either control or treatment groups. The primary participants in this study were adolescents and caregivers did not receive the intervention. Caregivers completed parental permission (consent) forms, demographic information related to their child and provided data for two of the secondary outcomes.
Participant milestones
| Measure |
Control Group
Automated reminders and individualized adherence feedback reports
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
|
Treatment Group
Automated reminders and individualized adherence feedback reports with social norms comparisons
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
|
Not Randomized (High Adherence)
This group demonstrated adherence rates of \>95% and thus were not randomized to either treatment arm per protocol
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
64
|
|
Overall Study
COMPLETED
|
14
|
17
|
47
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
17
|
Reasons for withdrawal
| Measure |
Control Group
Automated reminders and individualized adherence feedback reports
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
|
Treatment Group
Automated reminders and individualized adherence feedback reports with social norms comparisons
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
|
Not Randomized (High Adherence)
This group demonstrated adherence rates of \>95% and thus were not randomized to either treatment arm per protocol
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
5
|
|
Overall Study
Weaned from medicine
|
2
|
0
|
0
|
|
Overall Study
Withdrawn by study staff due to non-compliance with study procedures
|
2
|
1
|
12
|
Baseline Characteristics
Behavioral Economics and Adherence in Teens (BEAT!)
Baseline characteristics by cohort
| Measure |
Control Group
n=21 Participants
Automated reminders and individualized adherence feedback reports
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
|
Treatment Group
n=19 Participants
Automated reminders and individualized adherence feedback reports with social norms comparisons
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
|
Not Randomized
n=64 Participants
No interventions were provided to these participants as they demonstrated high adherence and were not eligible for randomization based on the run-in period.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.2 years
STANDARD_DEVIATION 1.2 • n=99 Participants
|
14.9 years
STANDARD_DEVIATION 3.2 • n=107 Participants
|
15.6 years
STANDARD_DEVIATION 1.4 • n=206 Participants
|
15.4 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
101 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Monotherapy versus Polytherapy
Monotherapy
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
99 Participants
n=7 Participants
|
|
Monotherapy versus Polytherapy
Polytherapy
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Monotherapy versus Polytherapy
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Seizure Type
Focal
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Seizure Type
Generalized
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
|
Seizure Type
Unclassified
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Seizure Type
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Seizures in the Past 3 months
No
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
|
Seizures in the Past 3 months
Yes
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Seizures in the Past 3 months
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Family Insurance
Private
|
10 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
70 Participants
n=7 Participants
|
|
Family Insurance
Public
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Family Insurance
Public and Private
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Family Insurance
Not insured
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Primary Caregiver
Mother/Stepmother
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
83 Participants
n=7 Participants
|
|
Primary Caregiver
Father/Stepfather
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Primary Caregiver
Other: Grandmother, Uncle, Aunt
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Primary Caregiver
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Month 7Population: Adherence data missing for 2 participants
A total mean adherence rates will be calculated based on daily adherence rates captured through the SimpleMed Pillboxes or AdhereTech bottles. Scores range from 0-100%, with higher scores representing better adherence.
Outcome measures
| Measure |
Control Group
n=19 Participants
Automated reminders and individualized adherence feedback reports
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
|
Treatment Group
n=19 Participants
Automated reminders and individualized adherence feedback reports with social norms comparisons
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
|
|---|---|---|
|
Electronically Monitored Adherence
|
45.5 units on a scale
Standard Deviation 32.0
|
50.5 units on a scale
Standard Deviation 37.4
|
SECONDARY outcome
Timeframe: Month 9The Global Assessment of Severity of Epilepsy (GASE) is a one item clinician-rated measure of seizure severity. The total score ranges from 1-7, with higher scores representing more severe epilepsy
Outcome measures
| Measure |
Control Group
n=13 Participants
Automated reminders and individualized adherence feedback reports
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
|
Treatment Group
n=15 Participants
Automated reminders and individualized adherence feedback reports with social norms comparisons
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
|
|---|---|---|
|
Seizure Severity-Clinician Report
|
2.5 score on a scale
Standard Deviation 1.3
|
2.4 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Month 9Population: The number of participants analyzed does not match the participant flow as some participants did not complete this particular measure.
The Seizure Severity Scale-Adapted for Children is a caregiver-reported questionnaire, which is 9-items and assess seizure severity, including intrusiveness, frequency, length, and disruptiveness of seizures. A total score is calculated, ranging from 0-3, with higher scores representing worse seizure severity.
Outcome measures
| Measure |
Control Group
n=12 Participants
Automated reminders and individualized adherence feedback reports
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
|
Treatment Group
n=16 Participants
Automated reminders and individualized adherence feedback reports with social norms comparisons
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
|
|---|---|---|
|
Seizure Severity-Parent Report
|
0.98 score on a scale
Standard Deviation 0.55
|
1.11 score on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Month 9The PedsQL-Epilepsy Module is a 29 item measure with several subscales (Impact, Cognitive, Executive Functioning, Sleep, Mood/Behavior) will be used. Scores range from 0-100 for each subscale, with higher scores representing better quality of life.
Outcome measures
| Measure |
Control Group
n=13 Participants
Automated reminders and individualized adherence feedback reports
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
|
Treatment Group
n=16 Participants
Automated reminders and individualized adherence feedback reports with social norms comparisons
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
|
|---|---|---|
|
PedsQL Epilepsy Module - Parent Report
Impact (parent)
|
83.3 score on a scale
Standard Deviation 15.5
|
78.8 score on a scale
Standard Deviation 18.0
|
|
PedsQL Epilepsy Module - Parent Report
Cognitive (parent)
|
63.1 score on a scale
Standard Deviation 28.9
|
72.4 score on a scale
Standard Deviation 19.8
|
|
PedsQL Epilepsy Module - Parent Report
Sleep (parent)
|
60.3 score on a scale
Standard Deviation 17.1
|
65.1 score on a scale
Standard Deviation 22.2
|
|
PedsQL Epilepsy Module - Parent Report
Executive functioning (parent)
|
71.2 score on a scale
Standard Deviation 23.2
|
72.3 score on a scale
Standard Deviation 23.9
|
|
PedsQL Epilepsy Module - Parent Report
Mood/Behavior (parent)
|
66.5 score on a scale
Standard Deviation 18.5
|
67.2 score on a scale
Standard Deviation 23.2
|
SECONDARY outcome
Timeframe: 9-monthPopulation: The flow diagram differs in sample size as one less adolescent completed this measure. Thus, the sample size is n=12.
The PedsQL Epilepsy Module is a 29-item health-related quality of life instrument with five subscales, including Impact, Cognitive, Executive Functioning, Sleep, and Mood/Behavior). Scores range from 0-100, with higher scores representing better quality of life.
Outcome measures
| Measure |
Control Group
n=12 Participants
Automated reminders and individualized adherence feedback reports
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
|
Treatment Group
n=16 Participants
Automated reminders and individualized adherence feedback reports with social norms comparisons
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
|
|---|---|---|
|
PedsQL Epilepsy Module-Adolescent Report
Impact
|
80 score on a scale
Standard Deviation 13.5
|
82.8 score on a scale
Standard Deviation 20.7
|
|
PedsQL Epilepsy Module-Adolescent Report
Cognitive
|
73.6 score on a scale
Standard Deviation 19.9
|
71.6 score on a scale
Standard Deviation 26.1
|
|
PedsQL Epilepsy Module-Adolescent Report
Sleep
|
56.9 score on a scale
Standard Deviation 20.4
|
67.7 score on a scale
Standard Deviation 27.2
|
|
PedsQL Epilepsy Module-Adolescent Report
Executive Functioning
|
75.7 score on a scale
Standard Deviation 13.5
|
65.4 score on a scale
Standard Deviation 26.7
|
|
PedsQL Epilepsy Module-Adolescent Report
Mood/Behavior
|
65.4 score on a scale
Standard Deviation 15.1
|
71.9 score on a scale
Standard Deviation 28.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 7Population: Participant numbers are lower than the Participant Flow data as some participants did not complete this particular measure.
Adolescents completed this study specific Satisfaction measure, which was 23-items. This measure assesses satisfaction with the intervention content, relevance, helpfulness, and ease of use. Assessment of perceptions of the impact of what was learned from the intervention were also assessed. Eighteen of the items used a Likert format with the following ratings: Strongly Disagree, Disagree, Agree, and Strongly Agree. A total scale was calculated for the 18 items, which ranges from 18-72, with higher scores reflecting higher satisfaction. Finally, five open-ended items assessing what was most and least helpful about the intervention, what changes adolescents want to see in the intervention, and any additional input.
Outcome measures
| Measure |
Control Group
n=13 Participants
Automated reminders and individualized adherence feedback reports
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
|
Treatment Group
n=17 Participants
Automated reminders and individualized adherence feedback reports with social norms comparisons
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
|
|---|---|---|
|
Satisfaction-Teen Report Total Score
|
53.5 score on a scale
Standard Deviation 9.0
|
50.8 score on a scale
Standard Deviation 6.0
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group
n=21 participants at risk
Automated reminders and individualized adherence feedback reports
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individualized Adherence Feedback Report: Feedback report on individual adherence behaviors
|
Treatment Group
n=19 participants at risk
Automated reminders and individualized adherence feedback reports with social norms comparisons
Automated Digital Reminders: Reminders from electronic monitors via texts or alarms/lights
Individual Adherence Feedback Report with Social Norms: Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
|
|---|---|---|
|
Nervous system disorders
Epilepsy monitoring unit/overnight EEG
|
4.8%
1/21 • Number of events 1 • 9 months
We collected this data through medical chart review
|
21.1%
4/19 • Number of events 4 • 9 months
We collected this data through medical chart review
|
|
Cardiac disorders
Chest pain
|
4.8%
1/21 • Number of events 1 • 9 months
We collected this data through medical chart review
|
5.3%
1/19 • Number of events 1 • 9 months
We collected this data through medical chart review
|
|
Ear and labyrinth disorders
Ear tube removal/myringoplasty
|
0.00%
0/21 • 9 months
We collected this data through medical chart review
|
5.3%
1/19 • Number of events 1 • 9 months
We collected this data through medical chart review
|
|
Psychiatric disorders
Suicidal Ideation
|
4.8%
1/21 • Number of events 1 • 9 months
We collected this data through medical chart review
|
5.3%
1/19 • Number of events 1 • 9 months
We collected this data through medical chart review
|
Additional Information
Dr. Avani Modi
Cincinnati Children's Hospital Medical Center
Phone: 513-636-4864
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place